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  4. “Exempt” may not mean what you think it means

“Exempt” may not mean what you think it means

Exempt — in the dictionary, it means “not subject to or bound by a rule.” That definition does not apply to IRB-land, however.

Studies that qualify for exempt review status are still subject to IRB oversight and must be submitted through CLARA. “Exempt,” in this case, means that a study is not subject to the usual requirements of 45 CFR 46, but it still must meet some human subject protection requirements as described in UAMS IRB Policy 7.3. For example, while exempt status studies typically don’t involve getting a subject to sign a consent form, the IRB may still require the study to include some kind of consent process.

IRB Policy 7.3 also spells out what types of studies qualify for exempt status review. Exempt status studies do not need to go to  the convened IRB or to an expedited reviewer for approval; they can be handled in the office by IRB staff. And it is up to the IRB office to determine whether a study qualifies for exempt status processing, so please don’t be tempted to think, “Oh, it’s exempt; I don’t even need to submit to the IRB.” Even if you’re certain it meets the criteria for exempt status review, it must still be submitted through CLARA.

Posted by Edith Paal on November 19, 2015

Filed Under: Research News

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